How to Sell a CE Marked Medical Device in Great Britain: The Complete Checklist

Short answer: If your medical device or IVD is legally CE marked under the EU MDR or IVDR, you can place it on the Great Britain market without a separate UK approval. But CE marking is only one part of the picture. You still need to register the device with the MHRA, appoint a UK Responsible Person if you are based outside the UK, meet GB labelling expectations and run post-market surveillance that covers the UK.

On 21 October 2026 the UK government confirmed that CE marked medical devices will be recognised in Great Britain on a long-term basis. We covered the announcement itself in CE marking for medical devices in the UK: indefinite recognition confirmed. This guide picks up where that one leaves off. It is a practical checklist of everything else you need in place to sell a CE marked device in England, Scotland and Wales.

Does a CE mark mean I can sell my medical device in the UK?

In Great Britain, yes, provided the CE mark is valid and the device complies with the EU regulation it was certified under. You do not need a UKCA mark as well.

What a CE mark does not do is register you with the MHRA, give the regulator a UK point of contact or cover your UK post-market obligations. Those are separate requirements, and they are where we most often see manufacturers caught out.

It is also worth knowing:

• Devices certified under the older EU Directives (MDD, AIMDD, IVDD) are treated differently. Their recognition is expected to follow the EU transition timelines, which currently run to 31 December 2028 for most devices.
• The changes confirming long-term recognition still need to be made in legislation. The detail is expected before the current 30 June 2028 deadline.
• Northern Ireland follows different rules, covered below.

Step 1: Appoint a UK Responsible Person (if you are based outside the UK)

If your company is based outside the UK, you must appoint a single UK Responsible Person (UKRP) before placing devices on the GB market. The UKRP must be established in the UK and acts on your behalf with the MHRA.

A UKRP typically:

• Registers your devices with the MHRA
• Keeps a copy of your technical documentation, declaration of conformity and certificates available for the regulator
• Cooperates with the MHRA on vigilance, field safety corrective actions and requests for information
• Ends the arrangement and informs the MHRA if you act against your obligations

You need a written letter of designation that names the UKRP as your exclusive representative and sets out the tasks they will carry out. If you use UKCA marking, the UKRP's name and address must also appear on your labelling, outer packaging or instructions for use. For CE marked devices this is not currently required, though some manufacturers add it anyway.

Choosing a UKRP is more than an admin task. They need real access to your documentation and a clear process for passing incident information back to you quickly. You can read more in our guide to the UK Responsible Person.

Step 2: Register your devices with the MHRA

All medical devices and IVDs must be registered with the MHRA before they are placed on the GB market. Registration is not complete until you receive confirmation from the MHRA.

You or your UKRP will need:

• The manufacturer's legal name and address, exactly as shown on the labelling
• The UKRP letter of designation, where applicable
• For each device: its class, the applicable legislation, GMDN code and term, brand name, model or catalogue number, Basic UDI-DI and UDI-DI where applicable, and details of the notified body or Approved Body
• Conformity assessment certificates or a self-declaration for Class I devices

From 1 April 2026, the MHRA introduced an annual registration fee charged per GMDN category. Build this into your UK budget, and keep registrations up to date when products, addresses or certificates change.

Step 3: Check your labelling and instructions for use

Your existing EU labelling will usually work for Great Britain, with a few points to check:

• Language: labels and instructions for use must be in English.
• UKRP details: required on UKCA marked devices, and worth checking against current MHRA guidance for CE marked products.
• Conformity marking: the CE mark and notified body number must match your certificate.
• Claims: everything on the label, website and marketing must stay within the intended purpose in your technical file. Our article on key rules for marketing medical devices covers the common pitfalls.

Step 4: Make sure your technical documentation is ready for the MHRA

The MHRA can ask to see your technical documentation at any time. Your UKRP should be able to provide it, so it needs to be complete, current and available in English.

Check in particular that:

• Your clinical evaluation reflects the current version of the device
• Your risk management file has been reviewed recently
• Certificates are in date and cover all the models you sell in GB

Step 5: Run post-market surveillance that covers Great Britain

Since 16 June 2025, Great Britain has had strengthened post-market surveillance (PMS) requirements. They apply to devices on the GB market whether they are UKCA or CE marked.

In short, you need:

• A PMS system and plan for each device, proportionate to its risk
• A PMS report for lower-risk devices, or a periodic safety update report (PSUR) for higher-risk devices
• Serious incident reporting to the MHRA within 15 days, or faster for deaths, unanticipated serious deterioration (10 days) and serious public health threats (2 days)
• Trend reporting when non-serious incidents increase significantly

Many manufacturers run PMS for the EU and simply forget to route UK complaints and incidents to the MHRA. Make sure your complaint handling and vigilance procedures name the MHRA and your UKRP explicitly.

What about Northern Ireland?

Northern Ireland continues to follow EU rules under the Windsor Framework. That means:

• CE marking (or CE plus UKNI for devices assessed by a UK notified body) applies. UKCA alone is not accepted.
• From 28 May 2026, most devices placed on the Northern Ireland market are registered in EUDAMED rather than with the MHRA.
• Manufacturers based in Great Britain need an EU or Northern Ireland based authorised representative to place devices on the Northern Ireland market.

If you sell across the whole UK, plan for both sets of requirements.

Do I still need a UKCA mark?

Not if your CE mark is valid. UKCA marking remains available as a route to the GB market, and it is being updated through new UK pre-market regulations expected to take effect from mid-2027. Some manufacturers will still choose UKCA, for example if they only sell in Great Britain. For most companies already selling in the EU, CE marking will remain the simpler route.

Selling a CE marked device in GB: quick checklist

• Valid CE mark and in-date certificates covering every model sold in GB
• UK Responsible Person appointed with a signed letter of designation (non-UK manufacturers)
• All devices registered with the MHRA and annual fees paid
• English labelling and IFU, checked against current MHRA guidance
• Technical documentation complete, current and available to the MHRA
• PMS plan, reporting and vigilance processes that cover Great Britain
• Northern Ireland approach agreed, if you sell there

Frequently asked questions

Is CE marking still valid in the UK after 2028?

Yes. The UK government has confirmed that devices CE marked under the EU MDR and IVDR will be recognised in Great Britain indefinitely, subject to the changes being made in legislation. Devices under the older Directives are expected to follow EU transition timelines.

Do I need to register a CE marked device with the MHRA?

Yes. Every medical device and IVD placed on the GB market must be registered with the MHRA before it is sold, regardless of whether it is CE or UKCA marked.

Who needs a UK Responsible Person?

Any manufacturer based outside the UK that places medical devices or IVDs on the Great Britain market. The UKRP must be established in the UK.

Do UK post-market surveillance rules apply to CE marked devices?

Yes. The GB post-market surveillance requirements that came into force on 16 June 2025 apply to devices on the GB market, whichever conformity marking they carry.

Can I sell a UKCA marked device in Northern Ireland?

No. Northern Ireland follows EU rules, so devices need CE marking (or CE plus UKNI).

How Taylored Consultancy can help

We help medical device manufacturers get to market in the UK and EU and stay compliant once they are there. That includes acting as your UK Responsible Person, MHRA registration, labelling reviews and setting up post-market surveillance that works across both markets. Take a look at our UK medical device services, or see how we supported a Canadian manufacturer's UK launch.

If you would like to talk through your GB market plans, get in touch with our team.

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